Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03036137|
Recruitment Status : Unknown
Verified January 2017 by Dayse da Silva Souza, Federal University of Paraíba.
Recruitment status was: Not yet recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED|
|Estimated Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||May 31, 2017|
|Estimated Study Completion Date :||September 1, 2017|
Active Comparator: Active tDCS
Subjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex.
Device: Transcranial Direct Current Stimulation
Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.
Other Name: Direct current stimulator; Transcranial stimulator
Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
Device: Sham Transcranial Direct Current Stimulation
Sham tDCS sessions will last 20 minutes
Other Name: Sham stimulation
- Tinnitus Handicap Inventory [ Time Frame: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention. ]Assesses change in tinnitus from baseline to follow-up periods post interventions
- Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress [ Time Frame: Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention. ]Self assessment of tinnitus loudness and tinnitus distress.
- Acuphenometry [ Time Frame: Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention. ]Subjective assessment of the frequency, intensity and type of tinnitus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036137
|Contact: Dayse Souzafirstname.lastname@example.org|
|Dayse Souza||Not yet recruiting|
|Joao Pessoa, PB, Brazil|